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Medical Device Testing – Home Health Care Equipment

July 6, 2018

As medical care delivery has increasingly moved from a hospital or clinic setting to patient homes, a greater range of medical technologies are being used in nonclinical environments. Medical devices used in home health care need to be appropriate for the environment in which they are used. Environmental conditions such as heat and humidity, quality of utilities, and environmental air contaminants such as dust and animal dander are challenges that medical devices do not face in a controlled, clinical environment. Just as home health care nurses and aides receive special training for work in a variety of home environments, the medical equipment they use must go through different, and sometimes more vigorous testing than medical devices intended for hospitals.

Considerations for Medical Devices Designed for Home Care

EMC – FDA recommends that you consider using the FDA-recognized 60601-1-2 standard (currently the Edition 3:2007 is transitioning to Edition 4: 2014-2, deadline is 12/31/18). A device intended for home use should be immune to disturbance levels that can be expected in the home healthcare environment. Although not a requirement, the Agency generally finds testing to the following immunity tests levels acceptable for the home environment based on FDA’s experience with home use devices: Electrostatic Discharge (ESD): ± 8 kV contact discharge, ± 15 kV air discharge; Power frequency magnetic fields: 30 A/m at 50 Hz or 60 Hz; Conducted RF: 3 V rms outside industrial, scientific, and medical (ISM) and amateur radio bands between 0.15 MHz and 80 MHz, 6 V rms in ISM and amateur radio bands between 0.15 MHz and 80 MHz Radiated RF: 10 V/m, 80 MHz to 2.6 GHz You may provide justification for testing to alternative levels.

Wireless Technology: If a device incorporates radio frequency (RF) wireless technologies, the device description in the pre-market submission should contain a complete description of the exact wireless technology used, frequency and frequency band, output power, functions, including any alarm conditions communicated wirelessly, performance, and risk management. Compliance of RF wireless technologies with applicable technology standards and Federal Communications Commission (FCC) rules does not necessarily alleviate home use device safety and effectiveness concerns. Any submission for a device that includes RF wireless technology should address the areas of concern listed in FDA’s guidance Radio Frequency Wireless Technology in Medical Devices (August 13, 2013).

Particular points to address include quality of service needed, data integrity, coexistence, security, and EMC of the wireless signals based on the use of the data intended by the manufacturer.

Due to the increased use of RF wireless technology that operates in shared frequency bands, if applicable, you should carefully address RF wireless coexistence through testing the device with other common applications of RF wireless technology that can be expected to be present in the environment of use. If it can be expected that two or more similar devices will be operating wirelessly in close proximity (e.g., mobile or body worn devices located in a waiting room or the same room of a home), the ability to operate properly under these conditions should also be tested.